Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery (ISAR-PEBIS)
This study is currently recruiting participants.
Verified April 2010 by Deutsches Herzzentrum Muenchen
Sponsor:
Deutsches Herzzentrum Muenchen
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01083394
First received: February 26, 2010
Last updated: April 7, 2010
Last verified: April 2010
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Purpose
The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Disease |
Device: PTA Device: PTA with PEB Procedure: Percutaneous Transluminal Angioplasty (PTA) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS) |
Resource links provided by NLM:
Further study details as provided by Deutsches Herzzentrum Muenchen:
Primary Outcome Measures:
- Percentage diameter stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- All-cause mortality [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
- Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Time to onset of any of MAPE [ Time Frame: 3-24 months ] [ Designated as safety issue: Yes ]
- Binary restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percentage diameter stenosis in duplex ultrasound [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: conventional PTA
In stent restenosis is treated with PTA using a conventional balloon.
|
Device: PTA
PTA using a conventional balloon
Other Name: PACIFIC XTREME, Invatec
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
Other Name: PACIFIC XTREME or IN.PACT PACIFIC balloons
|
|
Experimental: PTA with PEB
In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
|
Device: PTA with PEB
PTA using a paclitaxel eluting balloon
Other Name: IN.PACT PACIFIC, Invatec
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
Other Name: PACIFIC XTREME or IN.PACT PACIFIC balloons
|
Detailed Description:
The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Exclusion Criteria:
- Acute ischemia and/or acute thrombosis of the SFA
- Untreated ipsilateral iliac artery stenosis >70%
- Not at least one vessel run-off
- Popliteal involvement with stenosis >70%
- Severe renal insufficiency (GFR <30 ml/min/m2)
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial.
- Patient's inability to fully cooperate with the study protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083394
Contacts
| Contact: Julinda Mehilli, MD | +49 89 12 18 ext 4582 | mehilli@dhm.mhn.de |
| Contact: Ilka V. Ott, MD | +49 89 41 40 ext 4360 | ott@dhm.de |
Locations
| Germany | |
| 1. Medizinische Klinik, Klinikum rechts der Isar | Recruiting |
| Muenchen, Germany | |
| Contact: Ilka V. Ott, MD +49 89 4140 ext 4360 ott@dhm.mhn.de | |
| Principal Investigator: Ilka V. Ott, MD | |
| Deutsches Herzzentrum | Recruiting |
| Muenchen, Germany | |
| Contact: Massimiliano Fusaro, MD +49 89 1218 ext 4566 fusaro@dhm.mhn.de | |
| Contact: Tarek Ibrahim, MD +49 89 1218 ext 4016 ibrahim@dhm.mhn.de | |
| Principal Investigator: Massimiliano Fusaro, MD | |
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
| Study Chair: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Ilka V. Ott, MD | Klinikum rechts der Isar |
More Information
No publications provided
| Responsible Party: | Prof. Dr. A. Schoemig, Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT01083394 History of Changes |
| Other Study ID Numbers: | GE IDE No. B00210 |
| Study First Received: | February 26, 2010 |
| Last Updated: | April 7, 2010 |
| Health Authority: | Germany: German Institute of Medical Documentation and Information |
Keywords provided by Deutsches Herzzentrum Muenchen:
|
PTA paclitaxel restenosis |
Additional relevant MeSH terms:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013